NEW DEFECTIVE DRUG RECALL AFFECTS SUDAFED, BENADRYL & TYLENOL NONPRESCRIPTION DRUGS. RECALL LINKED TO TROUBLED PENNSYLVANIA FACILITY MANUFACTURING PROBLEMS.
What’s the problem?
J&J / McNeil is currently recalling nearly 47 million packages of Sudafed and other nonprescription drugs due to insufficient cleaning procedures conducted at a Pennsylvania facility that has already been subject to a series of massive recalls. The products being recalled were manufactured at McNeil’s Fort Washington, Pa. facility before it was closed in April following an FDA investigation. Inspectors reportedly found manufacturing problems at the plant, including equipment covered with thick layers of dust and others held together with duct tape.
Specific Sudafed products affected by this recall include (Product Name/Lot Number/UPC):
SUDAFED PE® DAY & NIGHT COLD COATED CAPLETS 20 count
AFC075, ALC109, APC130, BAC015
300450115201
SUDAFED PE® COLD & COUGH COATED CAPLETS 10 count
AJM418
312547227308
SUDAFED PE® COLD & COUGH COATED CAPLETS 20 count
AJM350, AJM351, AJM363, AMM302, APM347, ASM351
312547227315
SUDAFED PE® NON-DRYING SINUS COATED CAPLETS 24 count
ALM329, ALM462, BAM200
312547227322
SUDAFED PE® SEVERE COLD COATED CAPLETS 12 count
AEM075, AHM430, ALM392, AMM329, AMM425, ASM356, BBM200
312547227339
SUDAFED PE® SEVERE COLD COATED CAPLETS 24 count
AFM061, AHM429, AHM442, AMM358, AMM423, APM426, ASM453, BCM136
312547227346
SUDAFED PE® NIGHTTIME COLD COATED CAPLETS 20 count
ALM428, ASM355, BAM262
312547227360
SUDAFED PE® SINUS HEADACHE COATED CAPLETS 72 count CLUB CODE
ABM043, ACM041, ACM055
ACM061, AEM089, AHM371
AHM377, AJM361, APM423
BAM267, BCM138, BCM178
300450227157
SUDAFED PE® SINUS HEADACHE COATED CAPLETS 48 count
AEM088, ALM391, BCM137, APM354, BAM266
312547227391
SUDAFED PE® Triple Action COATED CAPLETS 24 count
AEM106, AFM028, AHM437, AHM445, AJM303, AJM422, ALM319, ASM306, ASM353, BAM269, ALM320, ALM384
300450526243
